A Randomized, Open Label, Multiple Dose, Crossover Study to Compare the Safety and Pharmacokinetics Between "Rebamipide Sustained Release (SR) 150mg" and "Rebamipide Immediate Release (IR) 100mg" in Healthy Volunteers
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- Cmax
Study Overview
Brief Summary
This is a randomized, open label, multiple dose, crossover study to compare the safety and Pharmacokinetics (PKs) between two rebamipide formulations after multiple oral doses of "rebamipide SR 150 mg" and "rebamipide IR 100 mg" in healthy adult volunteers.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Other
- Masking
- None
Eligibility Criteria
- Ages
- 19 Years to 45 Years (Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Subjects who give consent to voluntary participation by signing the informed consent form
- •Healthy adult males aged ≥19 and ≤45 years at screening
- •Subjects with weight ≥50 kg AND body mass index (BMI) ≥18.0 and ≤27.0
Exclusion Criteria
- •Subjects with hypersensitivity to the active ingredient of the IP or other anti-ulcer agents or history of clinically significant hypersensitivity
- •Subjects with any past history of gastrointestinal diseases which can affect the absorption of the IP
- •Subjects who have participated in other clinical trial and received any other investigational products within 3 months before the expected date of IP administration
- •Subjects who have taken any inducers or inhibitors of drug metabolism enzyme
- •Subjects who have been on diets that may affect the absorption, distribution, metabolism, and excretion of a drug
- •Subjects who donated whole blood within 2 months or underwent apheresis within 1 month prior to obtaining informed consent or who did not agree to prohibit blood donation
- •Smokers who have smoked >10 cigarettes per day within the last 6 months
- •Subjects with any positive result on HBsAg, hepatitis C virus (HCV) Ab, HIV Ab, and venereal disease research laboratory (VDRL) tests
Arms & Interventions
Sequence A (RT)
[Sequence A (RT) & Sequence B (TR)] to receive the Investigational Product (IP) by the sequence in each period:
- Rebamipide IR 100 mg (R): Take one tablet each at 9 am, 3 pm and 9 pm on 1d (8d) with 150 mL of water. For 9 am dose, take under the fasting condition for ≥10 hours.
- Rebamipide SR 150 mg (T): Take one tablet each at 9 am and 9 pm on 1d (8d) with 150 mL of water. For 9 am dose, take under the fasting condition for ≥10 hours.
Intervention: Rebamipide SR 150mg (Drug)
Sequence A (RT)
[Sequence A (RT) & Sequence B (TR)] to receive the Investigational Product (IP) by the sequence in each period:
- Rebamipide IR 100 mg (R): Take one tablet each at 9 am, 3 pm and 9 pm on 1d (8d) with 150 mL of water. For 9 am dose, take under the fasting condition for ≥10 hours.
- Rebamipide SR 150 mg (T): Take one tablet each at 9 am and 9 pm on 1d (8d) with 150 mL of water. For 9 am dose, take under the fasting condition for ≥10 hours.
Intervention: Rebamipide IR 100mg (Drug)
Sequence B (TR)
[Sequence A (RT) & Sequence B (TR)] to receive the Investigational Product (IP) by the sequence in each period:
- Rebamipide IR 100 mg (R): Take one tablet each at 9 am, 3 pm and 9 pm on 1d (8d) with 150 mL of water. For 9 am dose, take under the fasting condition for ≥10 hours.
- Rebamipide SR 150 mg (T): Take one tablet each at 9 am and 9 pm on 1d (8d) with 150 mL of water. For 9 am dose, take under the fasting condition for ≥10 hours.
Intervention: Rebamipide SR 150mg (Drug)
Sequence B (TR)
[Sequence A (RT) & Sequence B (TR)] to receive the Investigational Product (IP) by the sequence in each period:
- Rebamipide IR 100 mg (R): Take one tablet each at 9 am, 3 pm and 9 pm on 1d (8d) with 150 mL of water. For 9 am dose, take under the fasting condition for ≥10 hours.
- Rebamipide SR 150 mg (T): Take one tablet each at 9 am and 9 pm on 1d (8d) with 150 mL of water. For 9 am dose, take under the fasting condition for ≥10 hours.
Intervention: Rebamipide IR 100mg (Drug)
Outcomes
Primary Outcomes
Cmax
Time Frame: From Period1/ Day1 to Period2/Day9
Peak Plasma Concentration of Rebamipide
AUClast of Rebamipide
Time Frame: From Period1/ Day1 to Period2/Day9
Area Under the plasma concentration versus time curve last of Rebamipide
Secondary Outcomes
- t1/2 β of Rebamipide(From Period1/ Day1 to Period2/Day9)
- Tmax of Rebamipide(From Period1/ Day1 to Period2/Day9)
- AUCinf of Rebamipide(From Period1/ Day1 to Period2/Day9)